Kornimate/medical-research-clean huggingface dataset:
a placebo and active controlled study of ono-6950 in asthmatic patients

Conditions: Asthma

Summary: the primary objectives of this study are: i. to determine the effect of single oral doses (20 and 200 mg) of ono-6950 versus placebo on exercise induced bronchoconstriction (eib) as percent attenuation in the decrease of forced expiratory volume in 1 second (fev1) after exercise challenge ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg of ono-6950 in asthmatic patients. the secondary objectives of this study are: i. to compare the effect of different (20 and 200 mg) single oral doses of ono-6950 versus montelukast (10 mg) on eib as percent attenuation in the decrease of fev1 after exercise challenge ii. to determine the ratio of responders/non-responders in fev1 for different (20 and 200 mg) single oral doses of ono-6950 in comparison to montelukast (10 mg) and placebo.

the study will examine if ono-6950 could alleviate eib in asthmatic patients. eligible patients will complete a randomized, double-blind, four-way crossover study. during each of four evaluation periods, patients will be administered a single dose of either 20 or 200 mg ono-6950, 10 mg montelukast, or placebo. each evaluation period include various assessments following exercise challenge in an ambulatory setting.

Eligibility criteria:
inclusion criteria: * patients of both genders, between 18 to 60 years of age, with bronchial asthma for at least 6 months and history of exercise induced bronchospasm * patients with fev1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing * screening exercise challenge demonstrates that the patient experiences a fall in fev1 of ≥ 20% * non-smokers with free from the usage of nicotine-containing products at least for a year prior to screening exclusion criteria: * previous history of life-threatening asthma, respiratory tract infection and/or exacerbation of asthma within 6 weeks prior to the first screening visit * history of being unable to tolerate or complete an exercise challenge and clinically significant multiple drug or food allergies * past or present disorders and diseases including, but are not limited to cardiovascular, malignancy, hepatic, renal, hematological, neurological, psychiatric, endocrine, or pulmonary other than asthma * patients with seasonal allergic rhinitis (sar) or seasonal allergic asthma,with significant symptoms that may confound study assessment * significant safety laboratory, ecg, or vital sign abnormalities that would place the patient at undue risk during the study procedures

Keywords: asthma adult
electrical impedance imaging of patients on mechanical ventilation

Conditions: Pneumothorax; Pulmonary Contusion; Pleural Effusion; Pulmonary Edema; Atelectasis; Hyperinflation; Emphysema; Acute Respiratory Distress Syndrome

Summary: the goal of this study is to evaluate the sensitivity and specificity of electrical impedance tomography (eit) as a bedside diagnostic tool for lung pathologies in patients who are mechanically ventilated. in electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. the computed properties are used to form an image, which can then be used for monitoring and diagnosis.

the goal of this study is to characterize the ability of the electrical impedance tomography system (hardware and software) to distinguish between lung pathologies by assessing the sensitivity and specificity as well as the overall agreement with the ct scan in terms of spatial resolution. the study will test, as well as refine, the mathematical algorithms needed to create meaningful outputs on adult patients receiving mechanical ventilation and who also have received or will be receiving a ct scan as part of their standard of care.

Eligibility criteria:
inclusion criteria: * patients admitted to the icu at medical center of the rockies and on mechanical ventilation * age greater than or equal to 18 * computed tomography of the chest during normal course of hospital admission exclusion criteria: * age \<18 * any skin disorder that would prevent placement of the electrodes on the chest wall * hemodynamic instability prohibiting patient from being moved to place the device

Keywords: electrical impedance tomography lung imaging
non-invasive tms neuromodulation for enduring balance & locomotion restoration in parkinson's disease

Conditions: Parkinson's Disease

Summary: this is a feasibility and exploratory pilot study of adjuvant transcranial magnetic stimulation (tms) to physical therapy (pt) for locomotion and balance rehabilitation in parkinson's disease patients.

the primary outcomes will be feasibility of pairing 10 pt training sessions for pb\&g with rtms therapy immediately following pt treatment session. secondary outcomes will be exploratory, documenting differential clinical effects of two 'active' rtms compared to 'sham' rtms, to investigate ability to improve motor and functional recovery outcomes. outcome measures will be a combination of assessments regularly conducted during pt treatment sessions validated in people with pd (these will doubly serve as our study measures) and several pd oriented outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of pd confirmed by a neurologist with expertise in movement disorders; * hoehn and yahr stage 2 to 4; * on l-dopa and/or dopamine agonist daily treatment regimen; * on a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3 months; * posture, locomotion and balance deficits requiring at least 10 sessions of pt. exclusion criteria: * history of seizure disorder, including febrile seizures, fainting spells or syncope of unknown cause(s); * neurological disorder other than pd including stroke (mild-to-moderate micro vascular disease is allowed), traumatic brain injury, brain tumors, hydrocephalus; * major or unstable medical illness; * pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed); * untreated depression; or beck depression inventory (bdi)\>22 * taking any of the following medications within the four weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, bupropion, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, and theophylline; * history of moderate or severe dementia, or history of mini mental state examination (mmse) \<20 or montreal cognitive assessment (moca) \<22; * physical therapy treatment contraindications as determined by physiotherapist.

Keywords: rehabilitation balance
gestational diabetes mellitus (gdm) in pregnant women

Conditions: Gestational Diabetes Mellitus; Pregnancy Complications

Summary: the purpose of the trial is to discover and predict the development of gdm of pregnant women in their first trimester.

gestational diabetes mellitus (gdm) is a type of diabetes that affects pregnant women and often develops in the middle and later stages of pregnancy. gdm can lead to adverse maternal outcomes such as preeclampsia, and postpartum hemorrhage, and undesirable infant outcomes such as macrosomia and neonatal hypoglycemia. gdm also increases the risk of long-term consequences such as the development of type 2 diabetes in mothers, metabolic syndrome, and cardiovascular diseases. gut microbiota has been shown to play a significant role in the etiology of metabolic illnesses, and recent studies have demonstrated that the gut microbiota of gdm women is altered compared to those of healthy women. this trial aims to identify biomarkers during the first trimester (week 8-week 12) that can predict the likelihood of developing gdm while also examining potential links between gdm and gut microbiota. to achieve these objectives, the investigators have designed a trial that involves the collection of fecal samples from pregnant women for microbiome analysis at different stages of pregnancy. although gdm is diagnosed at or after 24 weeks, the investigators will collect samples at the first, second, and third trimesters to determine if any alterations in the microbiome occur prior to symptom onset.

Eligibility criteria:
inclusion criteria: women between the age of 18-45 groups a and b have to be confirmed pregnant by blood test (confirmed by medical records) subgroups a1 and b1 are pregnant women in their first trimester subgroups a2 and b2 are pregnant women in their second trimester subgroups a3 and b3 are pregnant women in their third trimester exclusion criteria: history of smoking or drinking during the pregnancy history of chronic diseases (cardiac, kidney, diabetes, hypertension, ibd,etc). laxative use within 2 days prior to sample collection (the participant will be informed of the collection procedure by the recruiter and will be made aware of this requirement, we will also confirm when the first sample is taken through a phone call if for any reason the participant still made a mistake, will ask her to collect another sample to replace it) development of any serious pregnancy complication during the participation period (e.g preeclampsia, preterm birth, miscarriage, etc) excessive vomiting, diarrhea, or gastrointestinal symptoms for more than 5 consecutive days during the participation period. this will be confirmed through a weekly check-up call by the on-site recruiter or by dr.yin if the patient seeks treatment

Keywords: gestational diabetes mellitus
poa prospective repository

Conditions: Solid Tumor, Adult; Oncology

Summary: this repository is a multi-center, outcomes study designed to collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing caris molecular intelligence® (cmi) services for the treatment of cancer.

this repository is a multi-center, outcomes study designed to collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing caris molecular intelligence® (cmi) services for the treatment of cancer. prior to enrolling a subject, the subject's physician will have made the independent decision whether or not to utilize the drug associations provided by cmi and made clinical treatment choices as appropriate. thus, data captured and reported provides a "real world" perspective on diagnosis, treatment, cost, and outcomes. prospective data will be obtained only from consented patients or patients who have died or have been lost to follow-up. lost to follow-up is defined as a subject who has not returned for continued care or evaluation (e.g., disability, relocation or unresponsiveness). site coordinators are required attempt to contact the subject 3 times before deeming them lost to follow up. data collection and the protection of privacy are discussed in the methods section below. in addition to treatment and response data, initial diagnosis and staging results will be recorded as well as any recurrence information. as the investigators are capturing the subject's cancer treatment as a whole, results from pertinent cancer-related tests performed by outside entities for eligible subjects will need to be collected by the site coordinator and maintained at the site accordingly for reporting and monitoring purposes.

Eligibility criteria:
inclusion criteria: * subject's age must be greater than or equal to 18 years and must have received cmi testing exclusion criteria: * due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.

Keywords: molecular profiling biomarker analysis next generation sequencing
a study of pd-1/ctla-4 bispecific ak104 in relapsed or refractory peripheral t-cell lymphoma

Conditions: Peripheral T-cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of ak104，an anti- pd-1 and ctla-4 bispecific antibody, in subjects with relapsed or refractory peripheral t cell lymphoma. the subject will receive ak104 450mg q2w until unacceptable toxicity, confirmed disease progression, withdrawal of consent, or for a maximum of 24 months.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed advanced peripheral t-cell lymphoma. * relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatments. * eastern cooperative oncology group (ecog) physical fitness score is 0 or 1. * adequate organ functions * effective methods of contraception. * ability to provide written informed consent and to be compliant with the schedule of protocol assessments. exclusion criteria: * patients diagnosed as adult t cell lymphoma / leukemia (atll). * any prior exposure to pd-1/pd-l1、ctla-4 targeting agents. * previous allogeneic stem cell transplant within 3 months prior to enrolment, active graft vs host disease (gvhd), or requiring transplant-related immunosuppression. * serious systemic infections or local infections during the 2 months before screening. * history of cancer in 5 years before screening., including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved). * have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study. * has enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials. * received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * subjects who received immunomodulatory drugs in 4 weeks before screening, including thymosin, interferon and interleukin, et al. * patients who received radiotherapy, chemotherapy, targeted therapy (except tki), immunotherapy within 4 weeks before screening, and patients who received tki drugs within 2 weeks before screening.

Keywords: anti-pd-1 anti-ctla-4 bispecific
a study to evaluate the safety and antiretroviral activity of mk-0518 versus efavirenz in treatment naive hiv-infected patients, each in combination with truvada (0518-021 ext)

Conditions: HIV Infections

Summary: this study will investigate the safety and efficacy of mk-0518 versus efavirenz, in combination with truvada, as a therapy for human immunodeficiency virus (hiv)-infected patients not previously treated.


Eligibility criteria:
inclusion criteria: * participant is a male or female at least 18 years of age * participant is hiv positive * participant is naïve to antiretroviral therapy (art) and has not received any art exclusion criteria: * participant has received approved or experimental antiretroviral agents in the past * participant has been treated for a viral infection other than hiv such as hepatitis b virus infection with an agent that is active against hiv including but not limited to adefovir or lamivudine (= 7 days total) * participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz * participant has used another experimental hiv-integrase inhibitor * participant has a current (active) diagnosis of acute hepatitis due to any cause * participants with chronic hepatitis including chronic hepatitis b and/or c may enter the study as long as they have stable liver function tests
safety and efficacy of long-term daily use of mirapex®-la tablets in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: post-marketing surveillance (pms) to investigate the safety and efficacy of long-term daily use of mirapex®-la tablets in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: - patients with parkinson's disease who have never been treated with mirapex la tablets before enrolment will be included. exclusion criteria: - none
vitamin d levels and coronary catheterization

Conditions: Vitamin D Deficiency

Summary: decreased vitamin d levels are associated with increased inflammatory markers,and renin angiotensin levels. decreased levels were also found to be connected to increased cardiovascular mortality. we therefore hypothesise that in patients with pathological results of coronary catheterization we will find decreased levels of 25 hydroxy vitamin d. we will examine patients undergoing elective coronary catheterization and compare two groups: those with normal results and those with pathological results.


Eligibility criteria:
inclusion criteria:age * \>18 years, * no known ihd exclusion criteria: * renal failure , * medications including vitamin d, calcium ,phosphate * hyper or hypoparathyroidism, * abnormal calcium or phosphate values, * known pathological coronary catheterization.

Keywords: vitamin d coronary catheterization
cochlear implantation among adults and older children with unilateral or asymmetric hearing loss

Conditions: Severe Unilateral Sensorineural Hearing Loss

Summary: do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.

unilateral hearing loss is known to impair binaural hearing abilities. specifically, localization, speech understanding in noise, and binaural squelch suffer due to lack of binaural timing and level cues. this study is designed to examine how binaural hearing is improved following cochlear implantation on the impaired side. the study endpoints are collected at 6 months and 12 months post activation of the implant. this is not a funded study. all costs are billed through insurance for reimbursement. there is an insurance approval process that we move through after a participant has been evaluated at the mayo clinic and found to be a candidate for cochlear implantation.

Eligibility criteria:
adults * 18 years of age or older, * hearing loss in the ear to be implanted must such that speech understanding is not possible with a well fitted hearing aid. specifically, less than 40% monosyllabic word understanding when that ear is tested in the best-aided condition and the other ear is sufficiently occluded or masked. * onset of hearing loss in the adult group must be post-lingual (after three years of age) children * children 7 years of age and older * hearing loss in the ear to be implanted configured such that word understanding is less 40% in the best aided condition * onset of hearing loss in the pediatric group must be post-lingual (after three years of age)

Keywords: cochlear implant
multiple minor hepatectomies versus major or extended hepatectomies for colorectal liver metastases.

Conditions: Colorectal Liver Metastases; Colon Cancer

Summary: the performance of multiple minor hepatectomies (mmh) instead of major hepatectomies (mh) in patients with colorectal liver metastases (clm) is object of debate. we build a study, using the propensity score matched analysis, to compare the short- and long-term outcome of the tow groups of patients.

the aim of this study is to investigate the outcome of patients with colorectal liver metastases (clm) undergoing multiple minor hepatectomies (mmh) instead of major hepatectomies (mh). indeed, the performance of mmh versus mh in patients with clm is object of debate. for this purpose, the databases at two independent institutions were retrospectively reviewed. to control for confounding variable distributions, a propensity score-matched analysis 1:1 was performed, and the nearest neighbor-matching method with caliper distance of 0.01 was used. among 554 patients, 110 patients undergoing mmh and 110 undergoing mh were matched. they were similar in baseline characteristics, comorbidities, features of the primary tumors, and clm. primary outcomes were short- and long-term outcome.

Eligibility criteria:
inclusion criteria: * diagnosis of clm exclusion criteria: * uncertain diagnosis * lost at follow-up

Keywords: hepatectomy hepatic resection
efficacity of cognitive remediation treatment compared to a controlled group in young patient with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the aim of research is to test in a randomized clinical trial with active sessions, the efficacy of cognitive remediation therapy in children anorexia nervosa compared to a controlled group. the investigators want to confirm the efficacy of cognitive remediation treatment in children's flexibility problems.

in this research, the investigators want to evaluate remediation cognitive therapy in anorexia nervosa compared to a controlled group (relaxation) based on different factors that testified the cognitive improvement of patients: one week after therapy, six months after and one year after. those factors are: weight, perfectionism and food symptomatology, temperament, therapeutic alliance and change motivation, clinical evolution of anorexia nervosa, self esteem, executive functions, neuropsychological performance (flexibility and central coherence).

Eligibility criteria:
inclusion criteria: * pathology * dsm iv criteria of restrictive anorexia nervosa (an- r), but not requiring amenorrhea or dsm v * accepting and their parents to participate in the study ( signed consents ) * topics * female supported for an- r * aged 8 to 16 years * fluent french * inpatients or outpatients suffering of restrictive anorexia nervosa * treatments * supports standard load ( family psychotherapy , dietary management , medical monitoring ) * in case of anxiety or depression , patients may receive additional psychotropic prescription which should be mentioned in the record * treatments previously followed by patients and treatments for other conditions should be described exclusion criteria: * pathology * mental retardation * schizophrenia * organic brain disorder ( encephalitis , degenerative brain tumor , cerebral neuro- degenerative disease , multiple sclerosis , amyotrophic lateral sclerosis, epilepsy ) * metabolic pathology interfere with feeding or its regulation * trouble consumption current substance * severe somatic pathology , progressive or likely to be life -threatening * topics the subjects are not mastering the french language will not be considered * subjects or parents do not have sufficient capacity for understanding instructions and consent * no affiliation in social security ( beneficiary or legal )

Keywords: anorexia nervosa cognitive remediation therapy